Personalised medicine requires regulatory change, former FDA head says

doi:10.1136/bmj.a537

BMJ 2008;336:1461 (28 June), doi:10.1136/bmj.a537

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Personalised medicine requires regulatory change, former FDA head says

Bob Roehr

¹ Washington, DC

The first 150 words of the full text of this article appear below.

Regulatory changes are needed in the way that drugs are developed,approved, and paid for so that the potential of genetic andmolecular personalised medicine can be realised, a former headof the US Food and Drug Administration said at a forum in Washington,DC, last week.

"The goal is a more solid model of disease progression and amore solid understanding of when treatments are having an impacton particular patients," said Mark McClellan, the commissionerof the FDA from 2002 to 2004 and later head of the Medicaresystem. Under legislative changes passed last year the FDA ismoving towards a targeted development process and more effectivepost-marketing surveillance.

Dr McClellan said that use of validated biomarkers of CD4 countand viral load allowed rapid development of treatments for HIVand that genetic screening for potentially fatal hypersensitivityto the antiretroviral drug abacavir has been integrated intoclinical . . . [Full text of this article]

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